MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-25 for D R BURTON VPEP manufactured by D R Burton.
[66078368]
D r burton oscillatory vpep have multiple cracks and shards of plastic from patient dropping on floor. The d r burton oscillatory vpep devices consistently break and shatter. The concern is the patient will inhale or aspirate pieces of plastic in their lungs from the shattered mouthpiece.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067507 |
| MDR Report Key | 6282839 |
| Date Received | 2017-01-25 |
| Date of Report | 2017-01-25 |
| Date of Event | 2017-01-23 |
| Date Added to Maude | 2017-01-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | D R BURTON VPEP |
| Generic Name | PEP DEVICE |
| Product Code | BWF |
| Date Received | 2017-01-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D R BURTON |
| Manufacturer Address | FARMVILLE NC 27828 US 27828 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-01-25 |